BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERLINK SYSTEM

    MDR report key: 3171286 · Received June 14, 2013

    Report

    Report Number
    2031527-2013-00153
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 17, 2013
    Manufacturer
    ENDOLOGIX, INC.
    Product Code
    MIH
    PMA / PMN Number
    P040002
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLOGIX CONTINUES TO INVESTIGATE THE REPORTED EVENT. ENDOLOGIX WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4): REMAINS IMPLANTED IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 33 MONTHS POST-IMPLANT OF A BIFURCATED DEVICE AND A COMPETITOR'S PROXIMAL STENT GRAFT A TYPE III ENDOLEAK OF THE BIFURCATED DEVICE WAS IDENTIFIED. THE PATIENT WAS TREATED WITH AN INFRARENAL AORTIC EXTENSION AND AN ADDITIONAL BIFURCATED DEVICE, WHICH SUCCESSFULLY CORRECTED THE ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270987 POWERLINK SYSTEM INFRARENAL BIFURCATED STENT GRAFT MIH ENDOLOGIX, INC. 28-16-120BL W09-1321-001

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention